Developing and Testing a New Clinical Decision Aid for Menopause

  • Research type

    Research Study

  • Full title

    Improving NHS perimenopausal diagnosis and HRT prescription through AI, machine learning and big data: a single site, proof of concept study for women over the age of 35 transitioning through menopause

  • IRAS ID

    331340

  • Contact name

    Paola Borrelli

  • Contact email

    paolaborrelli@nhs.net

  • Sponsor organisation

    East & North Hertfordshire NHS Trust

  • Duration of Study in the UK

    1 years, 5 months, 28 days

  • Research summary

    There are 13 million people who are currently menopausal in the UK and whilst the average age of the menopause is 51 (where the condition is better understood) around one in 100 women (1.3m) experience the menopause before 40 years, where the condition is less understood, difficult to diagnose and symptoms are often mistaken for other conditions with average diagnosis time of two years and multiple GP and hospital appointments.
    These figures highlight the current wasted finances and inefficient use of resources, extended patient stress and dissatisfaction, and 20% of all cases, result in perimenopausal and menopausal women taking time off work - something that costs the UK economy 14m days per annum.
    To address these issues, Tuune are building a new AI-based menopausal and perimenopausal decision aid support platform for GPs and Patients, to enhance the patient care pathway and remove some of inefficiencies in the current system.
    The study is expected to run for 12 months starting in the final quarter of 2023. During the 6 months prior to the study beginning the Tuune research and tech teams will design and build the software, algorithms and clinician facing portal of the menopause decision aid. UK partners at East and North Hertfordshire NHS Trust (ENH-Trust) will begin recruiting patients into the study, following REC approval and follow up for 12 months. We are targeting 100 participants in our 12-month trial which will aim to answer the following outcomes.
    Does the use of the decision aid improve symptoms after prescription
    Does the use of the decision aid improve patient experience (reduce decisional conflict, increase self-efficacy, increase education and understanding etc)
    Does the use of the decision aid streamline NHS appointments for (peri-)menopausal women
    Does the sue of the decision aid reduce waiting lists for women with menopausal referrals

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    23/EE/0252

  • Date of REC Opinion

    17 Nov 2023

  • REC opinion

    Unfavourable Opinion